Vacuum Emulsifying Mixer – 30L GMP Pilot System for Pharmaceutical Production
Compact, Compliant, and Built for High-Viscosity Formulations
Product Overview
This 30L vacuum emulsifying mixer is a complete, closed-loop processing unit engineered specifically for pharmaceutical R&D labs and pilot-scale manufacturing. It handles high-viscosity formulations—ointments, creams, gels, suppository bases, and intravenous emulsions—with the consistency and cleanliness that cGMP and FDA-regulated environments demand.
The machine combines a bottom-mounted homogenizer, a scraper agitation system, and a vacuum deaeration module in a single compact footprint. Unlike top-entry designs, the bottom homogenizer uses gravity to feed thick, thixotropic materials directly into the high-shear zone. This eliminates dead zones, ensures uniform particle size reduction, and simplifies cleaning—all critical factors in multi-product pharmaceutical facilities.
What’s in the System
The unit follows a 3-in-1 modular architecture: a main emulsifying pot, separate oil and water phase pots, and an integrated control and vacuum system. Each component is built to pharmaceutical standards.
| Component | Description | Pharmaceutical Benefit |
|---|---|---|
| Main Emulsifying Pot | SS316L stainless steel, mirror-polished interior (Ra ≤ 0.4μm), three-layer jacket for heating/cooling, bottom homogenizer, tilt or sanitary bottom-valve discharge. | Zero dead-leg design prevents cross-batch contamination. Mirror finish cuts CIP time and validation effort. |
| Oil & Water Phase Pots | Dedicated pre-mix tanks (working volumes: oil 12–27L, water 25–38L) with independent heating. | Allows precise temperature control for each phase before vacuum transfer, improving emulsion stability. |
| Vacuum System | Vacuum pump achieving ≤ –0.09 MPa. | Removes entrapped air for bubble-free gels and ointments. Protects oxygen-sensitive APIs. Maintains a closed processing environment. |
Bottom Homogenizer – How It Works
The bottom-entry homogenizer is the core of this mixer. Its position at the vessel’s lowest point ensures that even the most viscous product flows directly into the rotor-stator workhead.
Operation principle: The high-speed rotor draws material downward and radially into the precision gap between the rotor and stator. There, the product is subjected to intense hydraulic shear, impact, and cavitation, breaking particles and droplets into a uniform emulsion. The action creates a continuous bottom-to-top circulation loop, so every portion of the batch passes through the shear zone multiple times.
| Parameter | Specification | Value for Pharma Production |
|---|---|---|
| Design Volume | 35 L (working capacity 20–30 L) | Ideal for clinical trial batches and small-batch production of high-value drugs. |
| Homogenizer Power | 1.1 – 3 kW (configurable) | Handles viscous materials up to 10,000–50,000 cP. |
| Homogenizer Speed | 0–3000 RPM (VFD adjustable) | Achieves particle sizes down to 0.2–2 μm – essential for bioavailability and product stability. |
| Wetted Materials | SS316L, mirror-polished | Corrosion-resistant and non-reactive. Meets cGMP and USP Class VI requirements. |
| Workhead Type | Multi-stage rotor-stator | Produces narrow particle size distribution, directly affecting drug release profiles. |
Agitation System
The scraper agitator works alongside the homogenizer to maintain a uniform temperature profile and prevent product from sticking to the vessel walls.
| Parameter | Specification | Pharmaceutical Value |
|---|---|---|
| Scraper Mixer Power | 0.75 – 1.1 kW | Enough torque to drive through thick gels and pastes. |
| Scraper Speed | 10–120 RPM (VFD adjustable) | Low speeds for gentle cooling (prevents shear degradation); higher speeds for efficient heating. |
| Agitator Design | Central stirrer + PTFE scrapers | Scrapers continuously wipe the wall, preventing localized overheating. Central stirrer ensures bulk homogeneity. |
Controls and Operation
The system uses a Siemens PLC with a touchscreen HMI for intuitive control. All critical parameters—temperature, speed, vacuum, and time—are monitored in real time.
| Feature | Specification | Benefit |
|---|---|---|
| Control Interface | Siemens PLC + HMI touchscreen (or premium push-button option) | Easy operation, real-time monitoring, and recipe management. |
| Key Components | Motors/drives from Siemens, ABB, or Schneider | High reliability, low downtime. |
| Data Logging | Optional, with alarm systems | Supports 21 CFR Part 11 compliance by providing electronic batch records. Reduces manual errors and ensures batch-to-batch consistency. |
Pharmaceutical Applications
This mixer is used across a broad range of drug product categories.
| Application Area | Examples |
|---|---|
| Topical Products | Ointments, creams, gels, lotions, pastes |
| Semi-Solid Dosage Forms | Suppository bases, pessaries |
| Parenteral & Ophthalmic | Intravenous lipid emulsions, ophthalmic ointments and suspensions |
| Oral Liquids | Syrups, suspensions, oral emulsions |
| Vaccines & Biologicals | Adjuvants, liposomes, complex biological formulations |
| Specialty Gels | Carbomer gels (ultrasound gel, personal lubricants, disinfectants) – vacuum deaeration eliminates cloudiness, high shear hydrates powders efficiently |
Technical Specifications
| Feature | Specification |
|---|---|
| Model | 30L Bottom Homogenizer Vacuum Emulsifying Mixer |
| Design Volume | 35 L |
| Working Volume | 20 – 30 L |
| Scraper Mixer Power | 0.75 / 1.1 kW |
| Scraper Speed | 10 – 120 RPM (VFD) |
| Homogenizer Power | 1.1 – 3 kW (configurable) |
| Homogenizer Speed | Up to 3000 RPM (VFD) |
| Heating | Electric or steam (optional) |
| Cooling | Water-cooled jacket |
| Vacuum Pump | 0.18 – 0.81 kW (≤ –0.09 MPa) |
| Lid Lifting | Automatic / hydraulic |
| Discharge | Tilt or sanitary bottom valve |
| Wetted Parts | SS316L, mirror-polished |
| Sealing | Mechanical seal (e.g., Bergman) |
| Overall Dimensions | 1620 × 900 × 1910 mm |
Scale-Up Range
The same design principle scales from lab to production. All models share the bottom-homogenizer architecture, making process transfer straightforward.
| Model Range | Working Volume | Mixer Power (kW) | Mixer Speed (rpm) | Homogenizer Power (kW) | Homogenizer Speed (rpm) |
|---|---|---|---|---|---|
| Lab | 5 – 30 L | 0.18 – 1.5 | 0 – 84 | 1.1 – 3.0 | 0 – 3000 |
| Pilot | 50 – 200 L | 1.5 – 3.0 | 0 – 63 | 3.0 – 5.5 | 0 – 3000 |
| Production | 500 – 1000 L | 4.0 – 5.5 | 0 – 65 | 7.5 – 11 | 0 – 3600 |
| Industrial | 2000 – 5000 L | 7.5 – 15 | 0 – 63 | 15 – 22 | 0 – 3200 |
Troubleshooting Common Issues
| Symptom | Likely Cause | Action |
|---|---|---|
| Panel blank | Power issue, blown fuse, faulty timer | Check connection, replace fuse, repair/replace timer |
| Motor won’t start | Overload, jammed parts, blown internal fuse | Reduce load, clear jam, replace fuse |
| Speed surges uncontrollably | Photoelectric sensor gap too large or dirty | Adjust sensor gap, clean sensor |
| Speed fluctuates | Unstable supply, load variation, cavitation | Stabilize power, adjust load, fix cavitation |
| Excessive / abnormal noise | Worn bearings, coupling, or PTFE bushings; misaligned head | Replace worn parts, reinstall workhead |
| Vacuum won’t hold | Valve issue, damaged seal, pump fault | Check valves, replace seal, repair pump |
| Scraper eccentric or worn | Misalignment, severe wear | Realign stirrer, replace scraper |
| Scraper jammed | Debris lodged | Remove foreign object, verify free movement |
Ordering and Customization
This mixer is available as a standard 30L unit, with custom capacities and options—such as steam heating, data logging, or specific seal materials—available upon request.
For a detailed quotation or to discuss your specific formulation requirements, contact our technical sales team.
